This role involves leading the development and application of quantitative systems pharmacology models to enhance drug discovery and development. Responsibilities include building mechanistic models, collaborating with cross-functional teams, and driving model-informed drug development strategies.
This role involves leading the development and application of quantitative systems pharmacology (QSP) models to advance drug discovery and development. Responsibilities include building mechanistic models, collaborating with cross-functional teams, and driving model-informed drug development strategies.
Lead the development and execution of CMC regulatory strategies for mRNA-based products across global submissions, including IND/CTA/BLA/MAA filings. Provide expert guidance on regulatory compliance, interact with health authorities, and support quality and manufacturing teams through change controls and submissions. Work within a multidisciplinary team at the Harwell site to advance Moderna’s pipeline in vaccines, oncology, and rare diseases.
This role involves leading CMC regulatory strategies and submissions for international markets, with a focus on mRNA-based products across vaccines, oncology, and rare diseases. The individual will guide global regulatory compliance, interact with health authorities, and support manufacturing and quality teams through regulatory interpretation and change control. It requires deep expertise in CTD-format filings and a proactive approach to managing multi-therapeutic regulatory programs in a fast-paced environment.
This role involves leading and executing strategic RWD partnerships to enhance GSK's R&D and commercial activities. Responsibilities include managing data access, ensuring operational execution, and collaborating with internal and external stakeholders to maximize the value of RWD in decision-making and evidence generation.
This role involves leading and executing strategic partnerships for Real World Data (RWD) to support GSK's R&D and commercial activities. Responsibilities include managing data partnerships, ensuring data access and analysis, and collaborating with various internal and external stakeholders to enhance the usability and impact of RWD.
This role involves leading the strategic execution of external data partnerships to enhance R&D and CPO activities. Responsibilities include defining and delivering RWD partnerships, ensuring data quality, and fostering relationships with academic institutions, health technology companies, and health systems to support regulatory approval and research.
This role involves leading clinical development for aging-related research within GSK’s Respiratory, Immunology & Inflammation unit. The Medical Director will design and execute clinical development plans, provide medical oversight, and integrate translational and clinical data to advance drug candidates. The position emphasizes cross-functional leadership, regulatory engagement, and innovation in addressing unmet needs in aging and immune science.
Leads clinical operations for a key asset across its full lifecycle, ensuring operational strategy aligns with scientific goals and regulatory requirements. Oversees study delivery, vendor and resourcing strategy, risk management, and cross-functional coordination. Ensures inspection readiness and high-quality data output while leading matrixed teams and influencing senior stakeholders globally.
The Clinical Operations Asset Lead is responsible for the strategic and operational delivery of clinical trials across the full asset lifecycle. This role involves setting and executing the program-level operational strategy, leading cross-functional teams, and ensuring high-quality, on-time delivery of clinical studies.
The Clinical Operations Asset Lead is responsible for the strategic and operational delivery of clinical trials across the full asset lifecycle. This role involves leading cross-functional teams, ensuring high-quality data, and driving innovative approaches to clinical research.
Leads clinical operations strategy across the full asset lifecycle, ensuring high-quality, on-time delivery of clinical studies. Works cross-functionally to shape clinical development plans, manage vendor and resourcing strategies, and maintain inspection readiness. Focuses on patient-centric, efficient study execution within a global, matrixed environment.
Leads clinical operations strategy and execution across the full lifecycle of a drug development asset, ensuring high-quality, compliant, and efficient delivery of global clinical trials. Works cross-functionally to shape development plans, manage risk, and align operational delivery with scientific and regulatory goals. Provides strategic leadership to study teams and represents clinical operations at senior governance levels.
Leads clinical operations for a key asset across its full lifecycle, setting the operational strategy and ensuring high-quality, on-time delivery of clinical studies. Works cross-functionally to align study execution with scientific and regulatory goals, driving innovation and efficiency while managing risks and stakeholder engagement. Serves as the primary accountability point for clinical operations within global governance structures.
Leads clinical operations for a key asset across its full lifecycle, setting the operational strategy and ensuring high-quality, on-time delivery of clinical studies. Works cross-functionally to align study design with strategic goals, manage vendor and resourcing strategy, and maintain inspection readiness. Serves as the primary escalation point for operational and quality issues, driving governance and risk management.
